Treatment for patient with congestive heart failure

ABSTRACT

The invention is directed to two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure which may be performed separately or together. One procedure involves providing a valved passageway through the patient&#39;s left ventricular wall at the apex of the patient&#39;s heart and advancing instruments through the valved passageway to connect the valve leaflets of the patient&#39;s heart valve, e.g. the mitral valve, in a “Bow-Tie” configuration to prevent or minimize regurgitation through the valve. The second procedure involves advancing a pacing lead and a pacing lead implanting device through a trocar in the patient&#39;s chest and implanting the pacing lead on an exposed epicardial region of the patient&#39;s heart wall. The pacing lead has a penetrating electrode which is secured within the heart wall.  
     Improved devices for these procedures include a minimally invasive grasping device for heart leaflets, a leaflet connector with artificial cordae tendenae and a pacing lead implant instrument.

RELATED APPLICATIONS

[0001] This application is related to and claims the priority ofProvisional Application No. 60/340,062, filed Dec. 8, 2001, ProvisionalApplication Serial No. 60/365,918, filed Mar. 20, 2002, and ProvisionalApplication Serial No. 60/369,988, filed Apr. 4, 2002, the entirecontents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] This invention is directed to therapeutic procedures for apatient's heart and to instruments and systems for such procedures. Theprocedures and the instruments and systems for such procedures areparticularly suitable for treating that patient suffering from thesymptoms of congestive heart failure (CHF), and particularly to thoseCHF patients exhibiting mitral valve regurgitation (MVR) and/or thoseexhibiting intraventricular conduction delay with resulting disturbanceof the synchronous right and/or left ventricular contractility.

[0003] There are over five million patients in the United Statessuffering from congestive heart failure and there are more than sevenhundred thousand new cases each year. For many of these patients medicaltherapy is not very successful. Recent trials have shown that asignificant number of CHF patient's benefit from percutaneousventricular pacing where pacing leads are introduced percutaneously andadvanced within the patient's vasculature until the leads are disposedwithin the patient's coronary sinus. However, ventricular pacing has notbeen found successful for a significant number of CHF patients for avariety of reasons. For example, in a number of procedures the coronarysinus cannot be cannulate and even if cannulated, the leads can becomedisplaced.

[0004] With many CHF patients, their ventricular ejection fraction isreduced due to mitral valve regurgitation (MR) resulting from dilatedcardiomyopathy, which is the deformity of the heart which accompaniesCHF. The MR in turn can exacerbate the cardiomyopathy leading to aworsening of the MR. The MR can also be the result of torn cordaetendenae which can also prevent complete closure of the valve.

[0005] Surgical procedures for mitral valve repair for MR typicallyinvolves valve support ring at the base of valve. Recent advances invalve repair include securing together the free edges of the mitralvalve leaflets by sutures staples and the like, commonly called“Bow-Tie” or “edge to edge” techniques. These procedures usually involveopen heart surgery including cardiopulmonary bypass and a sternotomy,although more recently some of these procedures have been performed byminimally invasive and percutaneous techniques which can reduce themorbidity of such procedures. Percutaneous procedures imposedifficulties in instrument design because the instruments for suchprocedures must be long enough, have small enough profile and havesufficient flexibility for advancement through the patient's vasculatureinto the patient's heart chamber. However, they must also be able toaccurately locate the operative ends of such instruments at a desiredlocation within the chambers of the patient's beating heart and bestrong enough to perform the required functions.

[0006] Techniques for Bow-Tie repair of mitral valves have beenmentioned in the patent literature, but specific instruments for suchtechniques are not yet commercially available.

SUMMARY OF THE INVENTION

[0007] This invention generally relates to minimally invasivetherapeutic procedures, including valve repair and ventricular pacing,for patients with CHF and to the devices and systems suitable for use insuch procedures. Specifically, one aspect of the invention is directedto gaining access to a patient's heart chamber through the wall of thepatient's heart, such as at the apex thereof, for repairing damaged orotherwise incompetent heart valves. The invention is also directed tothe attachment of a pacing lead to an exterior region of the patient'sheart wall for ventricular pacing. These procedures provided alone andparticularly when performed together provide significant relief andlonger life to symptomatic CHF patients. Moreover, due to the minimallyinvasive nature of these procedures, many of the CHF patient population,who are otherwise unsuitable for conventional treatments, may be treatedwith the present procedures.

[0008] While the procedure is primarily described herein for repairingdamaged or otherwise incompetent valves between chambers of thepatient's heart, the procedure can be employed in a variety oftreatments or diagnoses within the patient's heart chambers. Otherprocedures which may be performed include transmyocardialrevascularization, aortic stenting for aortic dissections and aneurysmtherapy, removal or clots and vegetations of prosthetic valves, excisionof heart tumors, stem cell and vascular growth factor implantation,ventricular septal defect closure and the like.

[0009] The procedure related to valve repair generally includes firstgaining access to the patient's chest cavity through a small openingmade in the patient's chest to gain access the chest cavity, preferablythough an intercostal space between two of the patient's ribs. Suchaccessing can be effected thorocoscopically through an intercostal spacebetween the patient's ribs by minimally invasive procedures wherein atrocar or other suitable device is placed within the passageway in thepatient's chest to the patient's chest cavity.

[0010] The patient's heart wall is pierced to provide a passagewaythrough the heart wall to a heart cavity such as the left ventricle,defined in part by the pierced heart wall. Preferably, the passageway isformed through a region of the heart wall at or near the apex of thepatient's heart. Suitable piercing elements include a 14 gauge needle. Aguide wire is advanced through the inner lumen of the needle into theheart chamber and further advanced through the valve to be treated intoan adjacent heart chamber. The needle may then be removed leaving theguide wire in place. A valve is advanced over the guide wire andinstalled in the ventricular wall passageway which is configured toenable passage of instruments for the procedure through the heart wallinto the heart chamber while preventing loss of blood through thepassageway. The valve may be permanently or temporarily within the heartwall passageway. A dog-boned shape balloon can be utilized to seat thesecuring elements of the valve within the passageway.

[0011] The instruments for performing the procedure may then be passedthrough the valve seated in the passageway. The proximal ends of theseinstruments extend out of the patient to allow the instruments to bemanipulated to more accurately position the operative ends of theinstruments at the desired location within the heart chamber to performthe procedure and to operate the operative member which may be providedon the distal ends of these instruments.

[0012] An expandable stabilizing instrument is provided to stabilize thetissue structure within the heart chamber at a grasping location, suchas the mitral valve leaflets upon which the procedure is to beperformed. In the case of mitral or atrioventrical valve repair, thestabilizing instrument is a catheter having one or more expandablemembers on a distal location thereof, such as an inflatable balloon orexpandable arms, which can engage the atrial surface of the valveleaflets to stabilize and urge the valve leaflets toward a graspinglocation in the left ventricle to allow the grasping member to engageand hold the valve leaflets together so that the free ends of theleaflets can be secured together by suitable connecting elements.Suitable leaflet connecting elements include clips, staples, and thelike. The distal extremity of the catheter having the expandable memberis advanced into the atrial chamber. The expandable member(s) e.g. aninflatable balloon or one or more arms or struts are expanded and thenthe catheter is pulled proximally to engage the expandable member(s)against the atrial side of the valve leaflets and push the leaflets intothe grasping location within the ventricular chamber.

[0013] An elongated grasping device with at least a pair of graspingmembers such as jaws on the distal end thereof for grasping tissuestructure is advanced through the valve until the distal end extends outof the distal end of the guiding catheter. The grasping members or jawsof the grasping device are operated from the proximal end of thegrasping device which extends out the proximal end of the guidingcatheter extending out of the patient. The jaws of the grasping deviceare opened to engage the stabilized valve leaflets in the graspinglocation and then closed to grip the leaflets so that the free edges ofthe valve leaflets are placed into an operative position for the Bow-Tierepair. The free ends of the grasped valve leaflets may be joined orotherwise secured together by suitable connecting elements such asclips, staples and the like. Once the free edges of the valve leafletsare secured together, the instruments for the procedure may be withdrawnthrough the valve in the heart wall and then the opening in thepatient's chest. The valve will close upon instrument removal toeliminate or at least minimize blood leakage through the valve. Thevalve may be left in place or removed and the passageway sutured closed.

[0014] When there is cordae tendenae damage with the heart valve,particularly when there is severance of the cordae tendenae from thevalve leaflet or the papillary muscle, repair of the valve leaflet, evenby means of the Bow-Tie technique, may not prevent reshaping of theventricular architecture which can reduce ventricular output. In thatinstance, it has been found that providing an artificial cordae tendenaesuch as a strand extending between the valve leaflets and the heart wallin generally the same orientation as the cordae tendenae will supportthe connected valve leaflets in more or less a normal manner to minimizeventricular deformation (e.g. dilation) which leads to decreased output.One end of the strand is secured to the connecting element securing thefree edges of the valve leaflets or to the free edges themselves and theother end of the strand is secured to a location on the heart wall,preferably on the exterior of the heart wall. The strand should berelatively inelastic or non-compliant to ensure an effective closedposition of the leaflets. In this case it is preferred that thepassageway through the ventricular wall pass through the apex region ofthe heart between the two papillary muscles in the left ventricle, sothat the pull on the valve leaflets by the strand secured to theleaflets is in approximately the same angle or orientation as thenatural pull by the competent cordae tendenae. This provides for abetter seal of the leaflets and thereby minimizes leakage through thevalve.

[0015] Other procedures which may also be performed through the seatedvalve in the heart wall passageway in addition to valve repair includetransmyocardial revascularization where a tissue ablation instrument isadvanced into the heart chamber for ablating tissue in an ischemicregion of the ventricular wall. It is generally thought that the tissueablation in the ischemic region causes angiogenesis and thusrevascularization which returns blood flow to the region. For TMRprocedures in some regions of the heart chamber, a secondary orsubselective guiding catheter having a preshaped distal tip may beneeded to orient the ablating tip to the desired ischemic region of thepatient's heart wall. A similar procedure may be utilized to ablateregions of the intraventricular wall to terminate or curtail arrhythmia.Other procedures are contemplated.

[0016] The minimally invasive placement of a pacing lead having apenetrating electrode is performed through a small opening in thepatient's chest in the intercostal space between ribs. The small openingis preferably provided with a suitable trocar such as those availablecommercially. The distal end of the pacing lead is introduced into thepatient's chest cavity through the trocar and the penetrating electrodeon the distal end of the pacing lead is inserted into an exposedepicardial surface on the patient' ventricular wall which defines theheart chamber such as the left ventricle. The pericardium is removedfrom the region to expose the epicardium. The proximal end of the pacinglead is configured to be connected to an electrical power source such asthose used for pacing purposes which produce a pulsed electrical outputof suitable frequency, current and voltage levels to control thecontraction of the ventricular wall to which the pacing lead isattached. The pacing lead may be tunneled subcutaneously to the powersource. The penetrating electrode preferably has hooks or other suitablestructures for preventing removal of the electrode from the heart wall.The penetrating electrode may take the form of an arrow, fish-hook orhelical coil. Other shapes are suitable.

[0017] The devices suitable for installing the pacing lead in theexterior of the heart wall are configured to be advanced through thetrocar or small opening in the patient's chest and press or otherwiseput the penetrating electrode of the pacing lead within the ventricularwall.

[0018] The output from the paced heart chamber is greatly increased andin conjunction with a repaired valve preventing or minimizingregurgitation, the CHF patient has a significant improvement in physicalwell being, life extension and quality of life.

[0019] These and other advantages of the invention will become moreapparent from the following detailed description and accompanyingexemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020]FIG. 1 is a perspective view of a patient's chest, partiallyillustrating the location of the patient's heart within the chestcavity, with part of the heart wall removed to expose the leftventricular chamber and illustrate torn cordae tendenae connected to oneof the valve leaflets.

[0021]FIG. 2A is a transverse cross-sectional view taken along the lines2-2 shown in FIG. 1 illustrating the incompetent mitral valve in aclosed condition during systole.

[0022]FIG. 2B is a transverse cross-sectional view taken along the lines3-3 shown in FIG. 2 illustrating the incompetent valve in an opencondition during diastole.

[0023]FIGS. 3A and 3B are transverse cross-sectional views similar tothose shown in FIGS. 2A and 2B but of a competent mitral valve.

[0024]FIGS. 4A and 4B are transverse cross-sectional views similar tothose shown in FIGS. 2A and 2B wherein the valve leaflets are securedtogether in a “Bow-Tie” configuration.

[0025]FIG. 5 is a partial elevational view in section of a patient'sleft ventricle illustrating a valve seated in the apical ventricularwall.

[0026]FIG. 6 is an enlarged perspective view of the valve shown in FIG.5.

[0027]FIG. 7 is a longitudinal cross-sectional view taken along thelines 7-7 shown in FIG. 6.

[0028]FIG. 8 is a top view of the valve taken along the lines 8-8 shownin FIG. 6.

[0029]FIG. 9 is a partial elevational view, in section of the left sideof the patient's heart illustrating the positioning of a guide wire inthe patient's heart interior with the shaped distal tip of a guide wirein the patient's left atrium.

[0030]FIG. 10 is a partial elevational view, in section of the left sideof the patient's heart illustrating the advancement of a grasping deviceover the guide wire shown in FIG. 9.

[0031]FIG. 11 is a partial elevational view, in section of the left sideof the patient's heart illustrating the positioning of the graspingmembers on the distal end of the grasping device shown in FIG. 10 overthe guide wire into the patient's left atrium.

[0032]FIG. 12 is a partial elevational view, in section of the left sideof the patient's heart illustrating the advancement of a ballooncatheter into an inner lumen of the grasping device for deploymentwithin the patient's left atrium

[0033]FIG. 13 is a partial elevational view, in section of the left sideof a patient's heart illustrating the inflation of the balloon on thedistal end of the balloon catheter within the patient's left atrium.

[0034]FIG. 14 is a partial elevational view, in section of the left sideof a patient's heart illustrating the positioning of the valve leafletsin a grasping location by the balloon catheter with the expandedgrasping members of the grasping device being disposed within the leftventricle in a position to grasp the valve leaflets.

[0035]FIG. 15 is a partial elevational view, in section of the left sideof a patient's heart illustrating the grasping of the valve leaflets bythe grasping members of the grasping device.

[0036]FIG. 16 is a partial elevational view, in section of the left sideof a patient's heart illustrating the connecting the free edges of thevalve leaflets with a clip in a Bow-Tie arrangement.

[0037]FIG. 17 is an enlarged view of the distal end of the graspingdevice as shown in FIG. 16 with a clip is position partially pressedinto a connecting relationship with the free edges of the valveleaflets.

[0038]FIG. 18 is a transverse cross-sectional view taken along the lines18-18 shown in FIG. 17 illustrating the clip partially connected to thevalve leaflets.

[0039]FIG. 19 is an elevational view of a grasping device embodyingfeatures of the invention.

[0040]FIG. 20 is a transverse cross-sectional view of the graspingdevice shown in FIG. 19 taken along the lines 20-20.

[0041]FIG. 21 is an enlarged longitudinal cross-sectional view of thedistal end of the grasping device with a valve leaflet connecting memberslidably disposed within the inner lumen of the grasping device.

[0042] FIGS. 22-24 are transverse cross-sectional view taken along thelines 22-22, 23-23 and 24-24 of the grasping device shown in FIG. 21.

[0043]FIG. 25 is a transverse cross-sectional view taken along the lines25-25 illustrating the pusher bar pushing the clip along the guide waylumen of the grasping device shown in FIG. 19.

[0044]FIG. 26 is an enlarged elevational view of the clip with aartificial cordae tendenae strand secured to the closed end of the clip.

[0045]FIG. 27 is a partial elevational view, in section of the left sideof a patient's heart illustrating the artificial cordae tendenaeextending from the clip to the exterior of the patient's heart.

[0046]FIG. 28 is a perspective view of a patient's chest, partiallyillustrating the location of the patient's heart within the chestcavity, with part of the heart wall removed to expose the leftventricular chamber and illustrating placing the penetrating electrodeof a pacing lead within the heart wall defining in part the leftventricle.

[0047] FIGS. 29-31 illustrate a suitable minimally invasive device forimplating a pacing lead in a patient's heart wall.

[0048]FIGS. 32 and 33 illustrate an alternative embodiment of aminimally invasive device for implating a pacing lead in a patient'sheart wall.

[0049]FIG. 34 illustrates another minimally invasive device forimplating a pacing lead in a patient's heart wall.

[0050] The drawings are for the most part schematic presentations andnot to scale.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0051]FIG. 1 illustrates a patient's heart 10 with the left side of theheart in partial cross-section schematically showing the patient's leftatrium 11 and left ventricle 12 with a mitral valve 13 disposed betweenthe left atrium and the left ventricle having a posterior valve leaflet14 and an anterior leaflet 15. Each of the valve leaflets 14 and 15 havecordae tendenae 16 and 17 respectively which are connected to theleaflets and to papillary muscles 18 and 19 respectively within the leftventricle at the apex 20 of the heart. The posterior leaflet 14 of themitral valve 13 is shown with its cordae tendenae 16 partially torn. Thefree edge 21 of the posterior leaflet is uncontrolled due to the torncordae tendenae which makes the valve incompetent to close completelywhen the heart contracts during systole. This result in regurgitation ofblood back through the valve which in turn results in lowered bloodoutput for the left ventricle. The anterior valve leaflet 16 is shownwith its cordae tendenae 17 completely attached.

[0052]FIGS. 2A and 2B illustrate the closed and open conditionrespectively of an incompetent mitral valve 13 such as that shown inFIG. 1. The free edge 21 of posterior valve leaflet 14 is unable toclose completely against the free edge 22 of anterior leaflet 15 due tothe torn cordae tendenae as depicted in FIG. 1. A similar leafletcondition may occur due to dilated ventricular architecture, i.e.dilated cardiomyopathy, characteristic of congestive heart failure.

[0053]FIG. 3A illustrates a healthy competent mitral valve 13 with valveleaflets 14 and 15 which is closed completely during systole to preventregurgitation of blood through the valve. FIG. 3B illustrates thecompetent mitral valve shown in FIG. 2A in an opened condition duringdiastole to allow blood to flow from the left atrium to the leftventricle.

[0054]FIGS. 4A and 4B illustrate the closed and opened conditions of amitral valve 13 in which the free edge 21 of posterior valve leaflet 14and the free edge 22 of the anterior leaflet valve 15 are securedtogether in a Bow-Tie connection by a suitable clip, such as is shown inFIG. 25. During systole when the heart contracts, the clip holds thefree edges 21 and 22 of the valve leaflets together to minimize bloodregurgitation through the valve. However, during diastole, when theheart muscle relaxes and the blood pressure within the left ventricle isreduced, the mitral valve 13 opens up much like a competent valve butwith two openings 23 and 24 between the valve leaflets 14 and 15. Theinterference with blood flow through the two openings 23 and 24 of arepaired mitral valve with a Bow-Tie connection between the leaflets isminimal compared to the flow with a single opening for a competentmitral valve.

[0055]FIG. 5 illustrates a left side of a patient's heart such as isshown in FIG. 1 with an incompetent mitral valve 13 due to torn cordaetendenae14. A valve 30 embodying features of the invention is deployedwithin a passageway 31 through the free ventricular heart wall 32. As isshown in more detail in FIGS. 6-8, the valve 30 has a cylindricalstructure 33 which is secured within the passageway 31 by elements 34which may be barbs or hooks. The valve component 35 of valve 30 is aduck billed valve component formed of polymeric material which allow thepassage of instruments for deployment or treatment but prevent or atleast minimize loss of blood through the heart wall. The cylindricalstructure 33 may be in a form similar to a stent and is preferablyexpandable to facilitate its deployment. However, the cylindricalstructure 33 may have any suitable structure or be formed of anysuitable material which supports the valve component 35. The elementsmay be forced into the surrounding tissue of the heart wall by means ofa dumbbell shaped inflatable balloon.

[0056] FIGS. 9-18 depict a grasping device 40 which embodies features ofthe invention and the use of the device to secure the valve leaflets ina Bow-Tie connection. The grasping device 40 has an elongated shaft 41,a plurality of grasping members or jaws 42 on the distal portion of theshaft and finger operated handles 43 and 44 which operate the jaws 42through pull wires 45 and 46. The grasping members or jaws 42 arepivotally mounted at the pivot point 47 on the distal end of shaft 41.While only two jaws 42 are shown, three or more jaws may be employed.The elongated shaft 41 of grasping device 40 has an inner lumen 48extending therein to allow for the passage of instruments that aid oreffect the deployment of a connecting member to the free edges of thevalve leaflets to perform a Bow-Tie connection thereof as will bedescribed in more detail hereinafter. FIG. 22 is an enlarged elevationalview in section to illustrate the leaflet clip 49 and the pusher bar 50which pushes the clip through the inner lumen 48. As shown in moredetail in FIGS. 23-25, tapered grooves 51 and 52 are provided in thejaws 42 so that, as the clip 49 is pushed toward the distal ends of thejaws 42, the clip slides along the tapering grooves and is closedagainst free edges 21 and 22 of the leaflets 14 and 15 grasped by thejaws. The deployed leaflet clip 49 closed against the free leaflet edges21 and 22 in a Bow-Tie connection is shown in FIGS. 17 and 18. The innerlumen 48 continues through the jaws 42 to a port 51 to allow passage ofother instruments such as the distal portion of the balloon catheter 52which positions the leaflets 14 and 15 in the grasping location as shownin FIG. 14.

[0057] The use of the grasping device 40 is illustrated in FIGS. 10-18.After the one-way valve 30 is properly secured within the passageway 31through the ventricular wall 32, a guide wire 53 is advanced through thevalve 30 into the left ventricle 12 and further advanced through themitral valve 13 into the left atrium 11 as shown in FIG. 10. A graspingdevice 40 is mounted on the proximal end of the guide wire 53 whichextends out of the patient and is slidably advanced over the guide wirethrough the valve 30, and into the left atrium through the mitral valve13. The guide wire 53 at that point is slidably disposed within theinner lumen 48 of the grasping device 40. A balloon catheter 53 may thenbe advanced over the guideword 52 through the inner lumen 42 of thegrasping device 40 until the inflatable balloon 54 on the distal portionof catheter 53 is disposed in the left atrium. The balloon 54 isinflated by injecting inflation fluid through an inner lumen (not shown)in the shaft of the balloon catheter 53 by means of the syringe 55 asshown in FIG. 14. If the shaft of the balloon catheter 52 is stiffenough, the guide wire 53 may be withdrawn prior to insertion of theballoon catheter 52 and the catheter advanced through the inner lumen 48of grasping device 40 by itself.

[0058] After the balloon 54 is inflated within the left atrium 11, theshaft of the balloon catheter 52 is pulled proximally to press theinflated balloon 54 against the atrial side of the mitral valve leaflets14 and 15 to urge the leaflets into grasping location as shown in FIG.14. The jaws 42 may then be closed on the valve leaflets 14 and 15 asshown in FIG. 15. As previously described, the leaflet clip 49 may beadvanced through the inner lumen 48 by pusher bar 50 to close the clip49 against and through the grasped free edges 21 and 22 as shown inFIGS. 17 and 18. After the clip 49 has been deployed to form the Bow-Tieconnection, the grasping device 40 and any other devices that may bepresent are withdrawn from the patient's heart through the valve 30. Theduck-billed valve component 35 closes down after removal of the variousinstruments and prevents loss of blood from the left ventricle. Ifdesired, the valve 30 may be removed and the proximal opening of theventricular passageway sutured closed.

[0059] In an alternative embodiment is shown in FIG. 27 wherein anelongated strand 56 formed of relatively non-compliant material may haveone end 57 secured to the closed end of leaflet clip 49. Afterdeployment of the clip 49 to connect the free edges 21 and 22 of theleaflets 14 and 15 in a Bow-Tie connection, the proximal end 58 of thestrand 56 is pulled taut to position the leaflets 14 and 15 in a naturalposition to ensure proper closure during systole and then the proximalend 58 of the strand 56 is secured to the free ventricular wall 32,preferably to the exterior thereof, such as shown suturing with apledget 59. This embodiment is particularly suitable in those instanceswherein cordae tendenae connected to the valve leaflet are torn. Thestrand 56 then acts as an artificial cordae tendenae to the leaflet.However, care must be exercised when securing the proximal end 58 of thestrand 56 is secured to the heart wall 32 that the valve leaflets are ina natural position so as to prevent or reduce regurgitation through thevalve 13.

[0060] The hearts of many CHF patients exhibit intraventricularconduction delay with resulting disturbance of the synchronous rightand/or left ventricular contractility. As previously mentioned, a largepopulation of the CHF patients are not suitable candidates for or failpercutaneous delivery of pacing leads to provide relief from CHF. Inthese instances, it has been found that a pacing lead secured to theexterior wall defining in part the heart chamber exhibiting theconductance delay can better control the contraction of the heart toimprove the chamber's ejection.

[0061] As shown in FIG. 28, the pacing lead 60 can be deployed withinthe patient's chest cavity by minimally invasive techniques through atrocar 61 located in the intercostal space between the patient's ribs.The placement of the pacing lead 60 can be observed by an endoscopicvideo 62 extending through an intercostal space. Instruments tofacilitate the implantation of the helically shaped electrode 63 of thepacing lead 60 can be passed through the trocar 61 and the electrodesecured within the heart wall 32 by minimally invasive techniques. Thepacing lead 60 has its proximal end configured to be electricallyconnected to a pacing power source 63 which is preferably disposed at asubcutaneous location. The pulsed output of the power source 63 may becontrolled in a conventional manner to provide the desired contractionsto the heart wall to which the pacing lead is secured.

[0062] FIGS. 29 to 31 illustrate a minimally invasive embodiment havingfeatures of the invention to secure an electrode of a pacing lead withinthe free wall defining the left ventricle of the patient's heart tocontrol the contraction of the left ventricle and improve the outputthereof. This device 70 includes a tubular delivery member 71 having aproximal end 72 with a port 73, an enlarged distal end 74 with a port 75and inner lumen 76 extending within the tubular member from the proximalport 73 to the distal port 75. The distal end of the tubular member 71is enlarged to receive a longitudinally expansive member such asinflatable balloon 77. The balloon 77 is provided with an elongatedshaft 78 having an inner inflation lumen (not shown) which allowsinflation fluid to be introduced into the interior of the balloon toinflate the balloon. The distal end of tubular member 71 is providedwith a vacuum pod 79 to secure the distal end to the exposed surface ofthe free ventricular wall 32. The interior of the pod 79 is connected tothe vacuum tube 80 which is in turn configured to be connected to avacuum source (not shown). The pacing lead 81 has a collar 82 securedabout a distal portion thereof which is configured to be engage by theballoon 77 when the latter is inflated to drive the penetratingelectrode 83 on the pacing lead against the exposed ventricular wall 32so that the penetrating electrode 83 penetrates into and is securedwithin the ventricular wall. The tubular member 71 may have a flexiblesection 84 to facilitate articulation of the distal extremity of thetubular member 71 to aid in the placement of the vacuum pod 79 to theexterior of the heart wall 32. The vacuum pod 78 is configured to passthrough a trocar provided in an intercostal space between the patient'sribs.

[0063] The pacing lead 81 shown in FIGS. 29-31 is installed by firstmaking a small opening in the patient's chest and implacing a firsttrocar (not shown) having an inner lumen. Commercially available trocarsinclude trocars from U.S Surgical and others. A second similar trocar(not shown) is installed in a similar manner for a thorocoscope such asshown in FIG. 28. which allows the operating surgeon to view the regionin which the pacing lead is to be installed and to place a variety ofinstruments within the patient's chest cavity. Other trocars may also beinstalled for other purposes.

[0064] The lower left lobe of the patient's lung is moved out of the wayto expose the patient's heart. The pericardium on the free wall 32defining in part the patient's left ventricle is removed from thedesired epicardial site in which the pacer lead is to be secured. Thepacer lead delivery tube 71 is introduced into the patient's chestcavity through the first trocar and advanced within the chest cavitytoward the exposed epicardial surface. The open end of the vacuum pod 79on the expanded distal end of the delivery tube is pressed against theexposed epicardial surface and a vacuum is developed within the innerchamber of the pod to hold the distal end of the tubular member 71against the epicardial surface. Inflation fluid is introduced into theinterior of the balloon 77 through the inflation lumen in tube78. Theexpanded distal end 74 of the delivery tube 71 limits the radialexpansion of the balloon, so the balloon expands longitudinally in thedistal direction as shown in FIG. 31. The longitudinal expansion causesthe distal end of the balloon to expand against the flange secured tothe distal portion of the pacer lead. Balloon pressure on the collar 82drives the pacing lead toward the epicardial location on the exterior ofthe patient's heart and the penetration electrode 83 on the distal endof the pacing lead into the ventricular wall. The barbs 85 on thepenetration electrode secure the electrode within the heart wall andprevent the electrode from being pulled out of the wall. Electricalpulses from a suitable electrical power source are applied to theproximal end of the pacer lead. The electrical pulses are transmittedthrough the pacing lead conductor to the electrode secured within theheart wall. The pulses are emitted from the secured electrode into thetissue of the heart wall to pace the patient's left ventricle. Thepacing is controlled in order to increase the volume of blood pumped outof the heart chamber.

[0065] An alternative device 90 is shown in FIGS. 32 and 33 which has anelongated tubular shaft 91 with a proximal end 92, a distal end 93, asemispherical shaped housing 94 on the distal end with an annular vacuumchamber 95 around the lower edge of the semi-spherical housing. An innerlumen 96 extends through the tubular shaft 91 which is in fluidcommunication with the vacuum chamber 95 in the housing. The proximalend 92 of the tubular member 91 is configured to be connected in fluidcommunication with a vacuum source (not shown). A second tubular member97 extends through the tubular member 91 and is connected in fluidcommunication with the interior of balloon 98 located within thesemi-spherical housing in order to direct inflation fluid thereto. Apacing lead 99 extends along, but exterior to, the tubular member 91 andhas a distal end with a balloon support platform 100 and a tissuepenetrating electrode 101 extending away from the platform. The distalportion of the tubular shaft is provided with some degree of flexibilityin order to ensure that the spherical housing is in a proper orientationto be pressed against the exposed epicardial surface for sealing thevacuum chamber against the surface. With the vacuum chamber securedagainst the epicardial surface 102, the balloon 98 is inflated to drivethe supporting platform 100 and the connected penetrating electrode 101toward the epicardial surface. The electrode 101 is driven into the wallof the patient's left ventricle and the barbs 104 thereon secure theelectrode within the wall tissue to prevent its removal. Electricalpulses from a suitable power source may then be applied to the tissuewithin the heart wall to pace the contraction thereof as discussed aboveto increase the output of blood from the heart chamber. The balloon 98is releasably secured to the support platform 100 so that when theelectrode is driven into the heart wall, the balloon can be deflated andthe vacuum within the vacuum chamber of the semi-spherical housing maybe released and the assembly withdrawn from the patient through thetrocar through which it was delivered. The proximal end of the pacinglead may then be directed to the power source and connected thereto.

[0066] Another alternative embodiment is shown in FIG. 34, which has anelongated tube 110 with a grasping mechanism therein and a pair ofgrasping tongs 111 on the distal end of the mechanism configured to besecured to a pacing lead. The embodiment has a housing 112 on theproximal end with a rotating lead holder which when rotated rotates thepair of tongs 111 on the distal end of the mechanism. A button 113 isprovided to disengage the tongs from the pacing lead 114. The rotationof the tongs 113 causes the rotation of the pacing lead and the helicalelectrode 115 to screw into the heart wall. This device will soon beoffered by Medtronic as an epicardial lead implant tool (Model No.10626)which is designed to be used with a Model 5071 pacing lead.

[0067] Usually an additional (conventional) pacing lead is installed inthe patient's right ventricle for complete resynchronization of theheart chambers. The additional lead is preferably connected to the samepower source as the first described pacing lead which may be located inthe infraclavicular pocket in a conventional manner.

EXAMPLE

[0068] Twenty patients were selected (12 men, 8 women) forthorocoscopically direct left ventricular lead placement. The patientshad New York Heart Association Class III or IV congestive heart failurewith a mean ejection fraction of 20%±8%. All of the patients hadpreviously undergone transvenous right-ventricular lead placement andsubcutaneous implantation of a dual or triple chamber pacement but hadfailed transvenous left-ventricular lead placement due to suboptimalcoronary vein anatomy. Surgical entry into the left chest was carriedout through a 2 cm incision in the mid acillary line at the sixthintercostal space, following collapse of the left lung. A 15 mmthoracoport (U.S. Surgical) was inserted with the tip of the trocarpointing to the left should to minimize contact with the heart. A 5 mmrigid port was inserted inferolateral to the left nipple of the patientin the sixth intercostal space to allow insertion of a grasper such asthe U.S. Surgical Endograsper. Another 5 mm rigid port is inserted inthe fourth intercostal space at the anterior axillary line for a scopeand camera. A portion of the pericardium was removed to provide anexposed epicardial region for implantation of the helical electrode ofthe pacing lead. Screw in epicardiac leads (Medtronic 5071 and Guidant4047) were inserted under video control through the 15 mm trocar orrigid port. The leads were inserted into the epicardium by applyinggentle pressure and three clock-wise full rotations of the pacing leadholder. If pacing voltage thresholds were unacceptably high the pacinglead would be twisted one-quarter turn and then retested. Acceptablepacing lead placement is defined as 100% pacing at 2.5 volts or less.The video assisted left-ventricular lead placement was successful innineteen of the twenty patients. The one failure required an openthoracotomy.

What is claimed is:
 1. A minimally invasive method of treating apatient' heart having mitral valve regurgitation from a left ventricle,comprising: a. forming a small passageway in the patient's leftventricular wall defining in part the patient's left ventricle; b.seating a valve into the passageway formed in the left ventricular wall;c. advancing a grasping device through the valve into the leftventricle; d. advancing an expandable member through the valve, throughthe left ventricle, through the mitral valve into a left atrium distalto the mitral valve; e. expanding the expandable member within the leftatrium and engaging leaflets of the mitral valve and guiding theleaflets to a grasping location; f. grasping the leaflets in thegrasping location with the grasping device; and g. securing togetherfree edges of the leaflets grasped with one or more connecting members.2. The method of claim 1 wherein the seated valve allows for passage ofinstrument into and out of the left ventricle and minimizes blood flowfrom the left ventricle.
 3. The method of claim 1 wherein a strand issecured to the by one end thereof to one or more of the connectingmembers and by a second end to the ventricular wall to hold the mitralvalve in a desired position.
 4. The method of claim 1 wherein the strandis secured to the exterior of the ventricular wall.
 5. The method ofclaim 4 wherein the strand passes through the seated valve in theventricular wall.
 6. The method of claim 3 wherein the strand isrelatively non-compliant.
 7. The method of claim 5 wherein the strand isformed of a material selected from the group consisting of nylon,polyethylene terephthalate, polytetrafluoroethylene, and polyurethane.8. The method of claim 1 wherein the grasping device has an inner lumenand the expandable member passes through the inner lumen of the graspingdevice to advanced into the patient's heart.
 9. The method of claim 8wherein the inner lumen tapers to smaller dimension in the distaldirection within the grasping elements to close a leaflet clip whendistally advanced therein. 10 A minimally invasive method of treating apatient's heart which has a left ventricle that provides insufficientoutput, comprising: a. exposing an exterior region of the patient'sheart wall which defines in part the left ventricle; b. advancing apacing lead with a penetrating electrode through the patient's chestcavity to an exposed region of the patient's heart wall; c. securing thepacing lead to the exposed region of the patient's heart wall with thepenetrating electrode within the heart wall; and d. deliveringelectrical pulses to the pacing lead to control the contraction of theheart wall to which the pacing lead in secured.
 11. The method of claim10 wherein a small opening is formed in the patient's chest to gainaccess to the patient's chest cavity.
 12. The method of claim 10 whereinthe electrical pulses have a frequency, duration, current and voltagesufficient to control the contraction of the patient's left ventricle toincrease the output thereof.
 13. The method of claim 11 wherein a trocaris seated within the small opening in the patient's chest.
 14. Themethod of claim 10 wherein a second pacing lead is disposed in the rightventricle of the patient' heart and electrical pulses are emitted froman electrode on a distal portion of the second pacing lead having afrequency, duration, current and voltage sufficient to control thecontraction of the right ventricle to increase the output thereof.
 15. Amethod of treating a patient's heart with congestive heart failure dueat least in part to regurgitation through a mitral valve and ventricularconduction delay with resulting disturbance of the synchronousventricular contractility, comprising a. forming a small passageway inthe patient's left ventricular wall defining in part the patient's leftventricle; b. seating a valve into the passageway formed in the leftventricular wall; c. advancing a grasping device through the valve intothe left ventricle; d. advancing an expandable member through the valve,through the left ventricle, through the mitral valve into a left atriumdistal to the mitral valve; e. expanding the expandable member withinthe left atrium and engaging leaflets of the mitral valve and guidingthe leaflets to a grasping location; f. grasping the leaflets in thegrasping location with the grasping device; and g. securing togetherfree edges of the leaflets grasped with one or more connecting members;h. exposing an exterior region of the patient's heart wall which definesin part the left ventricle; i. advancing a pacing lead with apenetrating electrode through the patient's chest cavity to an exposedregion of the patient's heart wall; j. securing the pacing lead to theexposed region of the patient's heart wall with the penetratingelectrode within the heart wall; and k. delivering electrical pulses tothe pacing lead to control the contraction of the heart wall to whichthe pacing lead in secured.
 16. A minimally invasive system for treatinga patient's heart having heart valve regurgitation, comprising: a. avalve configured to be secured within a passageway formed through thepatient's heart wall to provide instrument passageway into a chamber ofthe patient's heart defined in part by the heart wall through which thepassageway is formed; b. a tissue grasping device configured to extendthrough the valve secured within the passageway into the chamber of thepatient's heart and having at least two grasping members configured tograsp valve leaflets; c. a tissue securing assembly to secure a tissueconnecting member to at least one free edge of a valve leaflet.
 17. Theminimally invasive system of claim 16 wherein the grasping aws of thegrasping device grasp the valve leaflets with free edges exposed tofacilitate securing the free edges together with the connecting member.18. A minimally invasive system for treating a patient's heart having achamber providing insufficient output, comprising: a. a valve configuredto be secured within a passageway formed through the patient's heartwall to provide an instrument passageway into a chamber of the patient'sheart defined in part by the heart wall through which the passageway isformed; b. a tissue grasping device configured to extend through thevalve into the chamber of the patient heart and to grasp free edges ofvalve leaflets; c. a tissue securing assembly advanceable through thevalve to secure one or more connecting members to at least one free edgeof a valve leaflet. d. a pacing lead configured to be advanced into thepatient's chest cavity through a small opening in the patient's chest anto be secured to an exterior region of the patient's heart; and e. anelongated pulse transmitting member having one end secured to the pacinglead and another end configured to be connected to a source of energypulses.
 19. A system for treating a patient with congestive heartfailure including a regurgitating heart valve, comprising: a. at leastone connecting member for securing together free edges of the patient'sregurgitating heart valve; and b. at least one strand having one endsecured to the at least one connecting member and one end configured tobe secured to a heart wall.
 20. A minimally invasive system forinstalling a pacing lead to an exterior region of a free wall of apatient's heart, comprising: a. a delivery tube having a proximal end, aport in the proximal end, a distal end, a port in the distal end, aninner lumen extending from the proximal end to the distal end and influid communication with the ports therein and a securing pod on thedistal end to releasably secure the distal end of the delivery tube tothe exterior region of the patient's free heart wall; b. a pacing leadslidably disposed within the inner lumen of the delivery tube with adistal electrode which is securable within the patient's heart wall ofthe exterior region and a collar on a distal portion of the leadproximal to the distal electrode; c. an expandable member at the distalend of the delivery tube configured for distal expansion to engage thecollar on the distal portion of the lead and to drive the distalelectrode into the heart wall of the exterior region. d. a drivingmember on the distal end of the delivery tube configured to engage thecollar on the distal portion of the lead and drive the lead distally anddrive the electrode of the lead into the heart wall of the exposedregion of the patient's heart.
 21. A method of treating a patient havingCHF, comprising: a. providing a pacing lead having a pulse emittingelectrode on the distal end thereof; b. advancing the pacing leadthrough a small opening in the patient's chest; c. securing the pulseemitting electrode on the distal end of the pacing lead within a freewall of the patient's heart defining in part the patient's leftventricle; d. emitting electrical pulses from the electrode to pace thecontractions of the patient's left ventricle to increase the blood flowout of the left ventricle.
 22. A minimally invasive system fordelivering a pacing lead to an exposed region of a patient's freeventricular wall defining in part the patient's left ventricle,comprising: a. an elongated pacing lead having a distal end with aventricular wall penetrating electrode and a distal end configured to beconnected to an electrical conducting relationship with a suitablepacing power source b. an elongated delivery tube having a proximal end,a distal end configured to pass through a small opening in the patient'schest, an inner lumen extending through the delivery tube configured toslidably receive the pacing lead and a pod on the distal end of thedelivery tube to secure the distal end of the delivery tube to theexposed region of the patient heart wall. c. a driving member on adistal portion of the delivery tube configured to engage a distalportion of the pacing lead and drive the tissue penetrating electrodethrough the exposed surface of the patient's heart wall to secure theelectrode within the heart wall.
 23. The minimally invasive system ofclaim 22 wherein the delivery tube has an expanded distal end.
 24. Theminimally invasive system of claim 23 wherein the driving member is aninflatable balloon which is disposed within the expanded distal end ofthe delivery tube.
 25. A minimally invasive system for treating apatient having CHF, comprising: a. means for accessing a CHF patient'sleft ventricle through a valved passageway in the free ventricular walldefining in part the patient's left ventricle; b. means for securingtogether free edges of the patient's mitral valve in a “Bow-Tie”configuration from within the patient's left ventricle; c. pacing meanshaving an electrode secured within a region of the CHF patient's freeheart wall defining in part the patient's left ventricle; and d. anelectrical power source electrically connected to the pacing means todeliver electrical pulses to the patient's free wall suitable to pacethe patient's left ventricle.
 26. A minimally invasive method fortreating a patient having CHF, comprising: a. accessing a CHF patient'sleft ventricle through a valved passageway in the free ventricular walldefining in part the patient's left ventricle; b. securing together freeedges of the patient's mitral valve in a “Bow-Tie” configuration fromwithin the patient's left ventricle; c. securing an electrode of apacing lead within a region of the CHF patient's free heart walldefining in part the patient's left ventricle; and d. deliveringelectrical pulses from an electrical power source to the pacing lead todeliver electrical pulses to the patient's free wall suitable to pacethe patient's left ventricle.